System and device for medically treating an individual

ABSTRACT

A system for medically treating/vaccinating an individual comprising a first syringe, containing an anticoagulant material therein, for drawing a sample of blood from the individual. A centrifuge means for centrifuging the sample of blood contained within the first syringe to obtain a buffy coat. A second syringe comprising a second plunger and at least one microtubule member containing one of a treatment agent and a vaccine antigen. At least one open end formed within the at least one microtubule member for drawing a portion of the buffy coat therein and exposing the buffy coat to one of the treatment agent and vaccine antigen. A second needle capable of being attached onto the second syringe for introducing the exposed sample into the individual to effect treatment/vaccination thereof. This system is capable of allowing a plurality of treatment agents and/or vaccine antigens to be simultaneously applied to an individual.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is closely related to co-pending application Ser. No.11/478,070, filed Jun. 29, 2006, entitled “A Method Of MedicallyTreating An Individual”.

FIELD OF THE INVENTION

The invention relates, in general, to a system and device to medicallytreat and/or immunize an individual and, more specifically, to a systemand device for using an immunogenic antigen exposed blood sample tomedically treat and/or immunize an individual.

BACKGROUND OF THE INVENTION

Immunization of individuals has long been a known technique forcontrolling diseases such as measles, mumps, rubella, polio, hepatitisand, more recently, chicken pox. Conventional immunizations delivereither an attenuated live strain of a pathogen or a killed organism oran immunogenic antigen derived from the targeted pathogen or itsproducts, or one produced using recombinant genetic technology.Classical immunization delivers the vaccine by injection or by theenteric route. This approach is very indirect, requiring the antigen tobe taken up by immunocytes before or after dispersion from the injectionsite to the surrounding tissue. The immunocytes then migrate tolymphatic nodes or the spleen where antigen processing continues, or,for live vaccines, where the attenuated vaccine strain organismsmultiply and are disseminated from. Exposure of immunocytes to theantigens or the attenuated pathogens triggers humoral and cellularmediated immune responses, which lead to absorption of antigens orelimination of attenuants followed by long lasting protection fromdisease caused by the respective pathogen(s).

The enteric route requires that the antigen or organism survive thenumerous barriers posed by the gastric acid, digestive enzymes,competing microorganisms and biologically active lumenal or tissuesubstances, to reach a site from which the antigen or attenuatedorganism or products derived from an organism can be absorbed and canstimulate the immune system inducing a protective response. Otherapproaches, such as anti-idiotype immunization, or DNA injection, havebeen proposed but have not yet proven efficacious or safe in humans.

The routes of immunization for conventional vaccines have beenparenteral (intramuscular, suscutaneous or intradermal) or oral/enteric.Evidence exists that other routes (rectal, aerosol/nasal, dermal, etc.)could be used, but various practical and safety limitations have blockedwidespread applications via these routes. Direct administration ofvaccines via the intravenous route has been avoided due to the possiblerisk of severe systemic allergies (anaphylaxis) in sensitiveindividuals, or the risk of embolization of vaccine components or ofair.

In any case, all routes to date are modeled on the existing concept ofmultiple vaccinations, using individual (monovalent) or combination(polyvalent) vaccines. A reduction in the total doses needed forparenteral vaccines has been limited by the lack of lasting immuneresponses after only one dose of some vaccines, by interference betweenantigens when combined, and sometimes by safety or stability issues.

The expense of and barriers to vaccination are aggravated not only bythe growing number of vaccines, doses, clinic visits for vaccinations,etc., but the need to manufacture multiple formulations free fromadventitious organisms, noxious ingredients and/or contaminants orimpurities. Additionally, the necessity of cold chain maintenance formany vaccines raises another barrier against vaccination in remote andimpoverished areas. Also, relatively large volumes and large doses ofmost current vaccines are needed to ensure that some of the vaccine isinjected into areas where it will come into contact with immunocyteswithin tissue, and to generate responses of protective magnitude.

Due to the increasing number of vaccines being introduced for diseasecontrol, an additional series of problems have arisen with the use ofconventional vaccines. These problems include:

(a) Excessive expense for the vaccine products, vaccine administration,storage and clinic/office visits.

(b) Problems of compliance with costly and complex vaccinationschedules.

(c) Unavailability of certain vaccines in impoverished areas.

(d) Growing dependence on health care workers for delivery of thevaccines.

(e) Lack of health care workers in many areas.

(f) Multiplicity of injections with complex schedules and injection sitediscomfort.

(g) Interference between certain antigens in polyvalent vaccines.

(h) Age restrictions for some vaccines.

(i) Production and supply limitations with frequent shortages.

(j) Safety concerns.

In view of the multiplicity of concerns associated with theadministration of conventional vaccines, there is a need in the art fora new and revolutionary system and device for immunizing individuals,both humans and animals, which mitigates the problems enumerated above.There is also a need in the art for a new and revolutionary system anddevice for medically treating individuals, which would effectivelydeliver various types of treatment material throughout an individual'sbody.

OBJECTS OF THE INVENTION

It is therefore an object of the invention to provide a system and adevice for immunization that minimizes the amount of antigen, attenuantor other immunogen needed and the number of doses and clinic visitsrequired, while making possible polyvalent simultaneous immunizations.

It is a further object of the invention to provide a system and devicefor immunization that reduces the costs of immunization by reducing dosequantity, number of doses needed, number of visits needed, and coldchain dependence of the vaccine.

It is another object of the invention to provide a system and a devicefor immunization that is capable of using whole blood or buffy coatcells.

It is a further object of the invention to provide a system and a devicefor the delivery of materials, in addition to antigens, or attenuants,throughout an individual's body such as therapeutic drugs, virusvectors, genes, DNA, RNA, isotopes, and other therapeutic substances.

It is yet another object of the invention to provide a system and adevice to facilitate the treatment of AIDS and other infectiousdisorders.

In addition to the various objects and advantages of the invention whichhave been described in some specific detail above it should be notedthat various other objects and advantages of the present invention willbecome more readily apparent to those persons who are skilled in therelevant art from the following more detailed description, particularly,when such description is taken in conjunction with the attached drawingFigures and with the appended claims.

SUMMARY OF THE INVENTION

Briefly, and in accordance with the forgoing objectives, the inventioncomprises a system for medically treating/vaccinating an individual.This system comprises a first syringe for drawing a sample of blood fromthe individual. The first syringe comprises a first needle, a firstplunger, and a tubular member extending between the first needle and thefirst plunger. This tubular member contains an anticoagulant therein. Acentrifuge means for centrifuging the sample of blood contained withinthe first syringe to obtain a buffy coat and to enable one to expressthe packed red blood cell layer or alternatively, the plasma layer toexpose the buffy coat at the syringe orifice by means of a dual aperture(capped) syringe, or by centrifuging the syringe with the orifice sideup. A second syringe comprising a second plunger and at least onemicrotubule member containing one of a treatment agent and a vaccineantigen. At least one open end formed within the at least onemicrotubule member for drawing a portion of the buffy coat therein andexposing the buffy coat to one of the treatment agent and vaccineantigen. A second needle capable of being attached onto the at least oneopen end of the at least one microtubule member for introducing theexposed sample into the individual to effect treatment/vaccinationthereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a first syringe for drawing a sample of blood from anindividual.

FIG. 2 shows a centrifuge means for centrifuging the sample of bloodcontained within the first syringe to obtain a buffy coat.

FIG. 3 shows the second syringe, including a plurality of microtubules,for withdrawing one of a buffy coat sample or a whole blood sample andexposing the sample to antigen or treatment material.

FIG. 4 shows the second syringe with an attachable needle forre-injection of the exposed sample of FIG. 3 into an individual.

DETAILED DESCRIPTION OF THE INVENTION

Prior to proceeding to a more detailed description of the invention, itshould be noted that identical components having identical functionshave been designated with identical reference numerals for the sake ofclarity.

Reference is now made to FIG. 1, which shows a first syringe, generallyindicated as 10, for drawing a sample of blood 11 from the individual.The first syringe 10 comprises a first needle 12, a first plunger 14,and a tubular member 16 extending between the first needle 12 and thefirst plunger 14. An anticoagulant material is contained within thetubular member 16 of the first syringe 10.

As illustrated in FIG. 2, a centrifuge means, generally indicated as 18,may be provided for centrifuging the sample of blood contained withinthe first syringe 16 to obtain a buffy coat or white blood cells 20 fromthe sample of blood. A cap 17 may be used to cap the first syringe 16during centrifugation. Any well-known centrifuge device may be used forcentrifuging the sample of blood. After centrifugation of theblood-filled syringe (with the aperture end up and removal of the cap),the plasma is pushed out until the buffy coat alone is present,beginning at the distal syringe aperture. The dimensions of the syringeaperture(s) and the antigen or treatment microtubule aperture mustprovide precise docking of the two syringe devices.

After centrifugation, as shown in FIG. 3, the tubular member 16 of thefirst syringe 10 shows an example wherein the first syringe 10 iscentrifuged with the outlet aperture up so that the buffy coat 20 isabove the packed red blood cells 21. If the tubular member 16 iscentrifuged with the outlet aperture down (capped), red blood cells willbe the bottom layer, below the buffy coat, and will be expressed tobring the buffy coat to the aperture. A second syringe, generallyindicated as 22, comprises a second plunger 24, which may be built intothe syringe, and at least one microtubule member 26 containing one of atreatment agent and a vaccine antigen. At least one open end 28 isformed within the at least one microtubule member 26 for drawing aportion of the buffy coat 20 therein and exposing the buffy coat 20 toone of the treatment agent and vaccine antigen. A second needle 30 isprovided which is capable of being attached onto the at least one openend 28 of the at least one microtubule member 26 for introducing theexposed sample 32 into the individual to effect treatment/vaccinationthereof.

The use of the centrifuge means 18 is optional as the system of thepresent invention does not require that the sample of blood becentrifuged in order to obtain the buffy coat layer. A portion of thewhole blood sample obtained from the individual may be directly exposedto the antigen or treatment material within the second syringe 22.

The first plunger 14 and the first needle 12 are capable of beingremoved from the tubular member 16 so that the tubular member 16 may beplaced directly into the centrifuge means 18 or stored for future use.Also, since the first plunger 14 and/or the first needle 12 can beremoved from the tubular member 16, the buffy coat or the whole bloodsample may be directly removed from this tubular member 16 with thesecond syringe 22.

At least one cap 17 may be provided for sealing the tubular member 16 toenable the tubular member 16 to be placed within the centrifuge means 18and/or a storage device.

The first syringe 10 can also include means to expel red blood cellsfrom within the tubular member 16 after subjecting the sample of blood11 to the centrifuge means 18. This means to expel red blood cells cancomprises the original first needle 12 which was removed to allow thesample to be centrifuged, another attachable needle, or any other wellknown means.

As stated above, a second syringe 22 comprises a second plunger 24 andat least one microtubule member 26 containing one of a treatment agentand a vaccine antigen. At least one open end 28 is formed within the atleast one microtubule member 26 for drawing a portion of the buffy coat20 therein and exposing the buffy coat 20 to one of the treatment agentand vaccine antigen. This second plunger 24 is capable of fittingloosely on the at least one microtubule 26 to prevent an airlock on theat least one microtubule 26 while drawing the buffy coat 20 therein.This design would allow the buffy coat 20 to be drawn into the at leastone microtubule 26 by means of capillary action. Alternatively, thesecond plunger 24 may be tightened to create an airlock and the buffycoat 20 may be drawn into the at least one microtubule 26 by means ofsyringe plunger pressure applied from the second plunger 24. It is alsonecessary for the second plunger 24 to be tightened to create an airlockso that the exposed sample may be introduced into the individual. Thesecond plunger 24 is sterile and has a volume that exceeds the deadspace of the second needle 30 and the at least one microtubule 26.

As many as eight or more microtubules 26 may be provided in the secondsyringe 22. Each of these microtubules 26 may be pre-coated with adifferent vaccine antigen or treatment material so that the individual'ssample of blood is capable of being simultaneously exposed to aplurality of these treatment agents and/or vaccine antigens. Theplurality of microtubules can be formed according to two embodiments. Inthe preferred embodiment, the second syringe 22 can include acylindrical member 36 having a diameter of approximately 4 mm or othersuitable diameter. A series of cylindrical openings or channels 38 canbe bored through this cylindrical member. Alternatively, a series ofseparate microtubules can be joined together by any well-known meanssuch as adhesive and the like. An outer sleeve member 34 is providedwhich surrounds this plurality of microtubules 26. The syringe outlet 39can have an opening of approximately 6 mm in diameter or any diameterlarge enough for the second plunger 24 to snuggly fit into the secondsyringe 22

Once the blood sample or buffy coat has been exposed to the treatmentmaterial or antigen, the second needle 30 may be attached adjacent tothis opening 28 for re-injection into the individual. This design allowsfor a plurality of treatment agents and/or vaccine antigens to besimultaneously applied to an individual. This design also allows for thetreatment of AIDS and other infectious disorders.

The invention has been described in such full, clear, concise, and exactterms so as to enable any person skilled in the art to which it pertainsto make and use the same. It should be understood that variations,modifications, equivalents and substitutions for components of thespecifically described embodiments of the invention may be made by thoseskilled in the art without departing from the spirit and scope of theinvention as set forth in the appended claims. Persons who possess suchskill will also recognize that the foregoing description is merelyillustrative and not intended to limit any of the ensuing claims to anyparticular narrow interpretation.

1. A system for medically treating/vaccinating an individual, saidsystem comprising; (a) a first syringe for drawing a sample of bloodfrom such individual, said first syringe comprising a first needle, afirst plunger, and a tubular member extending between said first needleand said first plunger, said tubular member containing an anticoagulant;(b) centrifuge means for centrifuging said sample of blood containedwithin said first syringe to obtain a buffy coat and to enable one toexpress the packed red blood cell layer or plasma layer to position thebuffy coat at an orifice of said first syringe; (c) a second syringecomprising a second plunger and at least one microtubule membercontaining one of a treatment agent and a vaccine antigen, (d) at leastone open end formed within said at least one microtubule member fordrawing a portion of said buffy coat therein through said orifice ofsaid first syringe and exposing said buffy coat to one of said treatmentagent and vaccine antigen; and (e) a second needle capable of beingattached onto said at least one open end of said at least onemicrotubule member for introducing said exposed sample into suchindividual to effect treatment/vaccination thereof.
 2. A system formedically treating/vaccinating an individual as recited in claim 1wherein at least one of said first plunger and said first needle arecapable of being removed from said tubular member.
 3. A system formedically treating/vaccinating an individual as recited in claim 2including at least one cap for sealing said tubular member to enablesaid tubular member to be placed within said centrifuge means.
 4. Asystem for medically treating/vaccinating an individual as recited inclaim 1 wherein said first syringe includes means to expel red bloodcells and/or a plasma layer from within said tubular member aftersubjecting said sample of blood to said centrifuge means.
 5. A systemfor medically treating/vaccinating an individual as recited in claim 1wherein said second plunger is capable of fitting loosely on said atleast one microtubule to prevent an airlock on said at least onemicrotubule while drawing said buffy coat therein.
 6. A system formedically treating/vaccinating an individual as recited in claim 5wherein said buffy coat is drawn into said at least one microtubule bymeans of capillary action.
 7. A system for medicallytreating/vaccinating an individual as recited in claim 1 wherein saidsecond plunger is capable of being tightened to create an airlock tointroduce said exposed sample into such individual.
 8. A system formedically treating/vaccinating an individual as recited in claim 1wherein said buffy coat is drawn into said at least one microtubule bymeans of syringe plunger pressure applied from said second plunger.
 9. Asystem for medically treating/vaccinating an individual as recited inclaim 1 wherein said at least one microtubule comprises a cylindricalmember including a plurality of microtubules extending therethroughcapable of being exposed to a plurality of one of said treatment agentsand vaccine antigens.
 10. A system for medically treating/vaccinating anindividual as recited in claim 9 including an outer sleeve membersurrounding said cylindrical member.
 11. A system for medically treatingan individual as recited in claim 9 wherein said plurality of one oftreatment agents and vaccine antigens are capable of beingsimultaneously administered to such individual through said secondneedle.
 12. A system for medically treating/vaccinating an individual asrecited in claim 1 wherein said at least one microtubule comprises aplurality of separate microtubules joined together capable of beingexposed to a plurality of one of said treatment agents and vaccineantigens.
 13. A system for medically treating/vaccinating an individualas recited in claim 12 including an outer sleeve member surrounding saidplurality of microtubules.
 14. A system for medically treating anindividual as recited in claim 12 wherein said plurality of one oftreatment agents and vaccine antigens are capable of beingsimultaneously administered to such individual through said secondneedle.
 15. A device for medically treating/vaccinating an individualcomprising: (a) at least one microtubule having a first end opening anda second end opening, said at least one microtubule containing at leastone of a treatment material and vaccine antigen; (b) means for drawing aportion of one of a buffy coat material and whole blood materialobtained from a sample of blood compatible with such individual throughsaid first end opening of said at least one microtubule to expose saidportion of one of said buffy coat material and said whole blood materialto said at least one of a treatment material and vaccine antigen; and(c) means for administering one of said exposed buffy coat material andwhole blood material to such individual to effect treatment/vaccinationthereof.
 16. A device for medically treating/vaccinating an individualas recited in claim 15 including a plunger positioned adjacent saidsecond end opening of said at least one microtubule.
 17. A device formedically treating/vaccinating an individual as recited in claim 16wherein said plunger is capable of fitting loosely on said at least onemicrotubule to prevent an airlock on said at least one microtubule whiledrawing one of said buffy coat material and said whole blood materialtherein.
 18. A device for medically treating/vaccinating an individualas recited in claim 17 wherein one of said buffy coat material and saidwhole blood material is drawn into said at least one microtubule throughsaid first end opening by means of capillary action.
 19. A device formedically treating/vaccinating an individual as recited in claim 16wherein said plunger is capable of being tightened to create an airlockto introduce said exposed sample into such individual.
 20. A device formedically treating/vaccinating an individual as recited in claim 16wherein one of said buffy coat material and said whole blood material isdrawn into said at least one microtubule by means of syringe plungerpressure applied from said plunger.
 21. A device for medicallytreating/vaccinating an individual as recited in claim 15 wherein saidat least one microtubule comprises a plurality of microtubules capableof being exposed to a plurality of one of said treatment agents andvaccine antigens.
 22. A device for medically treating/vaccinating anindividual as recited in claim 21 including an outer sleeve membersurrounding said plurality of microtubules.
 23. A device for medicallytreating/vaccinating an individual as recited in claim 21 wherein saidplurality of one of said treatment agents and vaccine antigens arecapable of being simultaneously administered to such individual througha needle attached to said first end openings of said plurality ofmicrotubules.
 24. A device for medically treating/vaccinating anindividual as recited in claim 21 wherein said plurality of microtubulescomprises a cylindrical member having a series of tubular openingsextending therethrough.
 25. A device for medically treating/vaccinatingan individual as recited in claim 21 wherein said plurality ofmicrotubules comprises a plurality of separate microtubules joinedtogether.
 26. A system for medically treating/vaccinating an individual,said system comprising; (a) a first syringe for drawing a sample ofblood from such individual, said first syringe comprising a firstneedle, a first plunger, and a tubular member extending between saidfirst needle and said first plunger, said tubular member containing ananticoagulant; (b) a second syringe comprising a second plunger and atleast one microtubule member containing one of a treatment agent and avaccine antigen, (c) at least one open end formed within said at leastone microtubule member for drawing a portion of said sample of bloodtherein and exposing said sample of blood to one of said treatment agentand vaccine antigen; and (d) a second needle capable of being attachedonto said at least one open end of said at least one microtubule memberfor introducing said exposed sample into such individual to effecttreatment/vaccination thereof.
 27. A system for medicallytreating/vaccinating an individual as recited in claim 26 wherein atleast one of said first plunger and said first needle are capable ofbeing removed from said tubular member.
 28. A system for medicallytreating/vaccinating an individual as recited in claim 26 wherein saidsecond plunger is capable of fitting loosely on said at least onemicrotubule to prevent an airlock on said at least one microtubule whiledrawing said portion of said sample of blood therein.
 29. A system formedically treating/vaccinating an individual as recited in claim 28wherein said portion of said sample of blood is drawn into said at leastone microtubule by means of capillary action.
 30. A system for medicallytreating/vaccinating an individual as recited in claim 26 wherein saidsecond plunger is capable of being tightened to create an airlock tointroduce said exposed sample into such individual.
 31. A system formedically treating/vaccinating an individual as recited in claim 26wherein said at least a portion of said exposed sample is drawn intosaid at least one microtubule by means of syringe plunger pressureapplied from said second plunger.
 32. A system for medicallytreating/vaccinating an individual as recited in claim 26 wherein saidat least one microtubule comprises a plurality of microtubules capableof being exposed to a plurality of one of said treatment agents andvaccine antigens.
 33. A system for medically treating/vaccinating anindividual as recited in claim 32 including an outer sleeve membersurrounding said plurality of microtubules.
 34. A system for medicallytreating an individual as recited in claim 32 wherein said plurality ofone of treatment agents and vaccine antigens are capable of beingsimultaneously administered to such individual through said secondneedle.
 35. A system for medically treating an individual as recited inclaim 32 wherein said plurality of microtubules comprises a cylindricalmember having a series of tubular openings extending therethrough.
 36. Asystem for medically treating an individual as recited in claim 32wherein said plurality of microtubules comprises a plurality of separatemicrotubules joined together.